Taiwan ACE Beads for Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia

Safety and Efficacy of Prostatic Artery Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia

In this proposal, the investigators plan to conduct a clinical trial to validate the efficacy and safety of microspheres (T-ACE Beads).

Study Overview

• Status: Unknown
• Conditions: Lower Urinary Tract Symptom; Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Device: Taiwan ACE Beads

Detailed Description

T-ACE Beads can be used for prostatic arterial embolization safely and efficiently. Furthermore, investigator's microspheres has advantageous characteristics in biodegradability, drug delivery capability, and cost-effectiveness. After the clinical trial, we anticipate introducing a new microsphere for Lower Urinary Tract Symptom/Benign prostatic hyperplasia patients, which is beneficial to the participants in precise medicine as well as in the pharmaceutical and medical device industry.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xi-Zhang Lin, MD; Phone Number: 6202/3624 886-6-2353535; Email: linxz@mail.ncku.edu.tw
• Study Contact Backup: Name: Hui-Yu Hung, Bachelor; Phone Number: 6202/3624 886-6-2353535; Email: z9908033@email.ncku.edu.tw

Study Locations

• Taiwan
  • Tainan, Taiwan
    • Recruiting
    • National Cheng Kung University Hospital
    • Contact: Xi-Zhang Lin, MD; Phone Number: 3624 886-6-2353535; Email: linxz@mail.ncku.edu.tw
    • Contact: Hui-Yu Hung, Bachelor; Phone Number: 3624 886-6-2353535; Email: z9908033@email.ncku.edu.tw
    • Principal Investigator: Yuh-Shyan Tsai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

A. Men ≥ 50 years of age. Healthy patients or volunteers without diagnosis of Lower urinary tract symptoms (LUTS) / Benign prostatic hyperplasia (BPH) will not be included.

B. Patients diagnosed of LUTS / BPH，International Prostate Symptom Score > 12 with mild to severe symptom of LUTS.

C. Prostate volume > 50 mL.

D. Urinary flow rate <15 mL / sec.

E. Ineffectiveness after 6 months of previous medical treatment, or the side effects are too difficult to tolerate.

Exclusion Criteria:

If patients meet any of the following criteria they may not be entered into the study:

A. Major pelvic disease, or other malignancies.

B. Prostate specific antigen of serum > 10 ng/mL, malignant tumor not yet rule out (prostate specific antigen PSA>10 ng/mL).

C. Had Prostate surgery.

D. Chronic bacterial prostatitis.

E. Renal dysfunction or bladder diverticulum stones caused by prostate disease obstruction.

F. Main organs (heart, lung, liver, kidney) dysfunction who are not eligible for clinical trials under physicians' consideration.

G. White Blood Cell< 2000 or Severe thrombocytopenia（Platelet count <50,000/μL)，or blood coagulation abnormalities uncorrectable .

H. Unable to follow-up by MRI 3 times.

I. Unable to follow-up by ultrasound or CT scan.

J. Unwilling to sign a written informed consent form.

K. Allergic to Iodine or other injections.

L. Acute bacterial prostatitis.

M. Patients with active urinary tract infections or recurrent urinary tract infections (>2/years), prostatitis, or interstitial cystitis.

N. Cases of biopsy proven prostate, bladder, or urethral cancer.

O. Patients with glomerular filtration rates less than 40 who are not already on dialysis.

P. Patients with bilateral internal iliac arterial occlusion.

Q. Patients with causes of bladder obstruction not due to BPH (eg urethral stricture, bladder neck contraction, etc).

R. Patients with neurogenic or bladder atonia.

S. Patients where embolization is not possible distal to collateral vessels feeding non-prostatic tissue.

T. Patients with major neurologic illnesses which could have symptoms that may be similar to or confused for BPH (eg multiple sclerosis, Shy-Drager syndrome, spinal cord injury, etc.).

U. Patients with urethral stents.

V. Other than hemorrhoidectomy or pelvic irradiation, patients who have undergone prior rectal surgery.

W. Patients who have started or changed their dosage of alpha blockers or 5-alpha reductase inhibitors in the month prior to prostatic artery embolization.

X. Allergic to pharmaceutical excipients related to Microspheres.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Taiwan ACE Beads microspheres; The maximum use of dosage will not exceed 100 milligrams. The embolization procedure usually lasts less than an hour.	Device: Taiwan ACE Beads; Similar with conventional Transcatheter Arterial chemo-embolization, radiologist use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients Survival (Safety)	Survival rate was evaluated since treatment day until the date of death or final observation.	An average of 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on Patient's Symptoms	Change on patients' International Prostate Symptom Score (IPSS)	Before treatment, one and three months after treatment
Change on Prostate Volume	Prostate volume measured using MRI	Before treatment, one and three months after treatment.
Change in serum Prostate Specific Antigen (PSA) concentration	Measurement of Prostate Specific Antigen in patients undergoing this treatment.	Before treatment, one and three months after treatment.

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Collaborators: National Cheng Kung University; National Research Program for Biopharmaceuticals, Taiwan; The Industrial Technology Research Institute
• Investigators: Principal Investigator: Yuh-Shyan Tsai, MD, Department of Urology, National Cheng Kung University Hospital, College of medicine, National Cheng Kung University, Tainan 70403, Taiwan

Publications and helpful links

General Publications

• Liu YS, Lin XZ, Tsai HM, Tsai HW, Chen GC, Chen SF, Kang JW, Chou CM, Chen CY. Development of biodegradable radiopaque microsphere for arterial embolization-a pig study. World J Radiol. 2015 Aug 28;7(8):212-9. doi: 10.4329/wjr.v7.i8.212.
• Noor A, Fischman AM. Prostate Artery Embolization as a New Treatment for Benign Prostate Hyperplasia: Contemporary Status in 2016. Curr Urol Rep. 2016 Jul;17(7):51. doi: 10.1007/s11934-016-0608-0.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 4, 2017

Study Record Updates

• Last Update Posted (Actual): October 17, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Microsphere; Transcatheter Arterial chemo-embolization
• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: A-BR-105-055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No